[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35304-35305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14202]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-2323]


Assessment of Adhesion for Topical and Transdermal Systems 
Submitted in New Drug Applications; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Assessment 
of Adhesion for Topical and Transdermal Systems Submitted in New Drug 
Applications.'' Transdermal delivery systems are designed to deliver a 
drug across the skin and into systemic circulation, whereas topical 
delivery systems are designed to deliver the drug to local tissue. 
There is pharmaceutical and other stakeholder interest in the 
development of new transdermal and topical products, and this guidance 
provides recommendations on the clinical assessment of adhesion for 
such products that will be submitted as new drug applications (NDAs) or 
supplemental new drug applications. This guidance provides additional 
study design and methodology recommendations on conducting in vivo 
adhesion studies. This guidance takes these developments into 
consideration. When final, this draft guidance will expand upon the 
recommendation for in vivo adhesion studies in section V., Special 
Topics, subsection A., Product Adhesion Considerations, in the draft 
guidance for industry Transdermal and Topical Delivery Systems--Product 
Development and Quality Considerations issued on November 21, 2019.

DATES: Submit either electronic or written comments on the draft 
guidance by August 31, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the

[[Page 35305]]

public, submit the comment as a written/paper submission and in the 
manner detailed (see ``Written/Paper Submissions'' and 
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2020-D-2323 for ``Assessment of Adhesion for Topical and 
Transdermal Systems Submitted in New Drug Applications.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Margaret Kober, Center for Drug 
Evaluation and Research (HFD-580), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 22, Rm. 5376, Silver Spring, MD 20993-0002, 
301-796-0934.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Assessment of Adhesion for Topical and Transdermal Systems 
Submitted in New Drug Applications.'' This draft guidance provides 
recommendations on the clinical assessment of the adhesive properties 
of topical and transdermal delivery systems (collectively referred to 
as TDS) intended for submission in an NDA or supplemental NDA. The 
amount of drug delivered into and through the patient's skin from a TDS 
is dependent, in part, on the ability of the TDS to remain in direct 
contact with the skin (adhesive properties). Adhesive properties are 
clinically important as a loss of TDS adhesion during wear can reduce 
the amount of drug delivered to the patient, potentially compromising 
effectiveness. Additionally, partial or full detachment of a TDS from a 
patient's skin may result in unintentional exposure of the drug to 
others, potentially compromising safety. This draft guidance includes 
key considerations for the design of the TDS adhesion clinical study, 
including the selection of endpoints and FDA's current thinking on 
acceptable adhesion performance in the in vivo setting.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Assessment 
of Adhesion for Topical and Transdermal Systems Submitted in New Drug 
Applications'' and will supersede in vivo recommendations in section 
V., Special Topics in the draft guidance for industry ``Transdermal and 
Topical Delivery Systems--Product Development and Quality 
Considerations'' issued on November 21, 2019 (84 FR 64319). It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 314 have been approved under OMB control 
number 0910-0001, and the collections of information for the electronic 
submission of drug establishment registration and drug listing 
information have been approved under OMB control number 0910-0045.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: June 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14202 Filed 7-1-21; 8:45 am]
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